WASHINGTON— FDA has received a consent decree from the U.S. District Court for the Eastern District of Michigan, Southern Division, to destroy prohormone products worth $1.3 million. The decree included more than 23,300 bottles of three products distributed by LG Sciences LLC, of Brighton, Mich., marketed for use by body builders and distributed on the Web and at retail under the names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.” On behalf of FDA, U.S.Marshalls seized the products back in early April 2008, but the company was fighting the action, saying the products were DSHEA-compliant.
FDA said lab tests showed the products, which were marketed as dietary supplements, contain one or more unapproved food additives and/or new dietary ingredients (NDIs) and lacked scientific support for safe use. They found Methyl 1-D and Methyl 1-D XL contained 1,4,6-androstatriene-3,17-dione, also known as “ATD” or 1,4,6-etioallocholan-dione; Formadrol Extreme XL contained ATD and 3,6,17-androstenetrione, also known as “6-OXO”—the substance at the center of the legal battle between suspended Phillies pitcher J.C. Romero and several supplement makers and retailers.
FDA stated both of these substances are steroids that inhibit the activity of the enzyme aromatase; they can be found in dietary supplements marketed as testosterone boosters. Also, 6-OXO was created by Patrick Arnold, the chemist behind many of the BALCO products involved in the Major League Baseball steroid scandal, which involved Barry Bonds and other key players.
The agency emphasized it has no scientific information concerning the safety of the condemned supplements or their ingredients and, therefore, cannot determine whether they represent a hazard to consumers. They advised consumers who use or have used the products to discuss their use with their health care professionals. They added anyone who has experienced an adverse event related to any of these products should also consult a healthcare professional, in addition to reporting the event to MedWatch adverse event reporting (AER) system.
At the time of seizure, LG Sciences called the FDA action “merely a preliminary step in determining compliance with food regulations.” The company disputed what it called a “temporary restraint of its products” but agreed FDA was only trying to protect consumers. Further, LG said an ambiguous DSHEA allowed for such a seizure, but the company was adamant the offending ingredients were not NDIs, as they have numerous studies backing their safe use and have been in competitor’s products for several years. At the time, LG said it looked forward “to assisting the FDA in clarifying this matter and the prompt return of its inventory.”
However, FDA won the consent decree. “The court order is the result of efforts by the federal government to protect consumers from products for which there is inadequate information to assure that they do not present a significant or unreasonable risk of illness or injury,” said Michael Chappell, acting associate commissioner for regulatory affairs at FDA. “It shows that the agency is prepared to use the necessary legal means to keep such products out of the marketplace.”
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